跳至主要内容
临床试验/NCT07742670
NCT07742670进行中(未招募)不适用

Effects of Scoliosis-Specific Three-Dimensional Exercises Combined With Pelvic Floor Muscle Training on Scoliosis Severity and Spinopelvic Parameters in Adolescents With Idiopathic Scoliosis

Gazi University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
36
试验地点
1
主要终点
Cobb Angle

研究概览

简要总结

The goal of this clinical trial is to evaluate the effects of scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training on scoliosis severity and spinopelvic parameters in adolescents with idiopathic scoliosis. The main questions it aims to answer are:

  • Does the addition of pelvic floor muscle training to scoliosis-specific three-dimensional exercises improve scoliosis severity compared with scoliosis-specific three-dimensional exercises alone?
  • Does the addition of pelvic floor muscle training improve spinopelvic parameters compared with scoliosis-specific three-dimensional exercises alone? Researchers will compare a scoliosis-specific three-dimensional exercise plus pelvic floor muscle training group with a scoliosis-specific three-dimensional exercise group to determine whether the combined intervention provides additional clinical benefits.

Participants will:

  • undergo baseline clinical and radiographic assessments;
  • be randomly assigned to one of the two intervention groups;
  • receive supervised treatment for 3 months according to the assigned intervention;
  • undergo follow-up clinical and radiographic assessments at the end of the intervention period.

详细描述

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity characterized by lateral curvature of the spine, vertebral rotation, and alterations in sagittal alignment. Conservative treatment, including scoliosis-specific three-dimensional exercises, is widely recommended for individuals with mild to moderate AIS to reduce curve progression and improve postural alignment and function.

The pelvic floor muscles contribute to lumbopelvic stability through their interaction with the diaphragm, abdominal muscles, and paraspinal muscles. Although alterations in trunk muscle function have been reported in individuals with AIS, the potential role of pelvic floor muscle training as an adjunct to scoliosis-specific exercise programs has not been adequately investigated.

This randomized controlled trial will compare scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training versus scoliosis-specific three-dimensional exercises alone in adolescents with idiopathic scoliosis. The study will evaluate the effects of these interventions on scoliosis severity and spinopelvic parameters after a 3-month treatment period. The findings may contribute to optimizing conservative rehabilitation strategies for adolescents with idiopathic scoliosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors were blinded to participants' group allocation throughout the study to minimize assessment bias.

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 10-18 years.
  • Diagnosed with adolescent idiopathic scoliosis and eligible for brace treatment.
  • Cobb angle between 20° and 45°.
  • Risser sign between 0 and
  • Able to comply with and regularly attend the assigned treatment program.
  • No neurological or psychiatric disorder.
  • Willing to participate in the study, with written assent from the participant and informed consent from a parent or legal guardian.

排除标准

  • Any contraindication to exercise.
  • Previous surgery involving the thoracic, abdominal, or pelvic region.
  • Previous scoliosis surgery or being a candidate for scoliosis surgery.
  • Any cognitive or mental condition that could prevent understanding or following the treatment program.
  • Non-idiopathic scoliosis, including neurological, congenital, or other secondary causes.
  • Receipt of any scoliosis treatment or pelvic floor muscle training within the previous year.
  • Diagnosis of urinary incontinence.
  • Regular participation in sports.

研究组 & 干预措施

Scoliosis-Specific Three-Dimensional Exercise

Active Comparator

Participants received supervised scoliosis-specific three-dimensional exercises for 3 months according to the study protocol.

干预措施: Scoliosis-Specific Three-Dimensional Exercise (Behavioral)

Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training

Experimental

Participants received supervised scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training for 3 months according to the study protocol.

干预措施: Scoliosis-Specific Three-Dimensional Exercise (Behavioral)

Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training

Experimental

Participants received supervised scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training for 3 months according to the study protocol.

干预措施: Pelvic Floor Muscle Training (Behavioral)

结局指标

主要结局

Cobb Angle

时间窗: Baseline and 3 months

Change in Cobb angle measured on standing posteroanterior spinal radiographs using the Cobb method.

次要结局

  • Angle of Trunk Rotation(Baseline and 3 months)
  • Apical Vertebral Rotation(Baseline and 3 months)
  • Spinopelvic Parameters(Baseline and 3 months)
  • Pelvic Floor Muscle Activity(Baseline and 3 months)
  • Pelvic Parameters(Baseline and 3 months)
  • Sagittal Spinal Alignment Parameters(Baseline and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Başar

Professor

Gazi University

研究点 (1)

Loading locations...

相似试验